WILMINGTON, Del.–(BUSINESS WIRE)–Incyte (Nasdaq:INCY) today reports 2024 second quarter financial results, and provides a status update on the Company’s clinical development portfolio.
“In the second quarter of 2024, total revenues grew 9% year-over-year, surpassing $1.0 billion for the quarter. The commercial performance during this period was driven by strong patient demand for Opzelura® (ruxolitinib) and growth across all indications for Jakafi® (ruxolitinib),” said Hervé Hoppenot, Chief Executive Officer, Incyte. “In R&D, we completed a strategic review of our pipeline and have further intensified our focus on clinical programs that we believe can be transformational for patients. The $2.0 billion share repurchase completed during the second quarter, underscores our confidence in our commercial portfolio, clinical pipeline and Incyte’s long-term value.”
Transformation of Pipeline
- Incyte announces a strategic review of its pipeline with an increased focus on high potential impact programs including, but not limited to:
- IAI/Dermatology: povorcitinib and MRGPRX2 and MRGPRX4, which were recently acquired from Escient Pharmaceuticals
- MPNs/GVHD: mCALR, JAK2V617Fi, BETi, and ALK2i
- Oncology: CDK2i, KRASG12Di and TGFßR2×PD-1
- The Company will discontinue further development of both oral, small molecule PD-L1 inhibitors, as well as LAG-3 monoclonal antibody, TIM-3 monoclonal antibody and LAG-3xPD-1 bispecific.
Recent Company Updates
- Incyte announces positive topline results from two Phase 3 clinical studies evaluating retifanlimab (Zynyz®), a humanized monoclonal antibody targeting programmed cell death receptor-1 (PD-1), in squamous cell anal carcinoma (SCAC) and non-small cell lung cancer (NSCLC). The Phase 3 PODIUM-303 study in SCAC met its primary endpoint of progression free survival and the Phase 3 PODIUM-304 study in NSCLC met its primary endpoint of overall survival. The safety analysis from both studies demonstrated that retifanlimab was generally well-tolerated with no new safety signals observed. Incyte plans to share the Phase 3 data from both studies in the second half of 2024. POD1UM-303 is a Phase 3, global, multicenter, randomized, double-blind study evaluating carboplatin-paclitaxel with retifanlimab or placebo in patients with inoperable locally recurrent or metastatic SCAC who have not previously been treated with chemotherapy. POD1UM-304 is a Phase 3, global, multicenter, randomized, double-blind study evaluating platinum-based chemotherapy with retifanlimab or placebo in patients with first-line, metastatic squamous or nonsquamous NSCLC.
- In June 2024, Incyte repurchased a total of 33,325,849 shares of its common stock at a price of $60.00 per share, for a total cost of approximately $2.0 billion, excluding fees and expenses. These shares represented approximately 14.8 percent of the Company’s total outstanding shares of common stock as of June 7, 2024.
- In May 2024, Incyte announced it completed the acquisition of Escient Pharmaceuticals, a clinical-stage drug discovery and development company advancing novel small molecule therapeutics for systemic immune and neuro-immune disorders. Under the terms of the agreement, Incyte acquired Escient and its clinical development portfolio, including EP262, a first-in-class, potent, highly selective, once-daily small molecule antagonist of Mas-related G protein-coupled receptor (MRGPRX2) and EP547, a first-in-class oral MRGPRX4 antagonist.
- In April 2024, Incyte and China Medical System Holdings Limited announced the Companies entered into a Collaboration and License Agreement, through a wholly-owned dermatology medical aesthetic subsidiary CMS Skinhealth, for the development and commercialization of povorcitinib, a selective oral JAK1 inhibitor, in Mainland China, Hong Kong, Macau, Taiwan Region and eleven Southeast Asian countries.
Jakafi:
Net product revenues for the second quarter 2024 of $706 million (+3% Y/Y):
- Paid demand increased 9% in the second quarter of 2024 versus the same quarter in the prior year, with growth across all indications.
- Year over year net product revenue growth was lower than paid demand growth due to higher channel inventory levels at the end of the second quarter of 2023 versus the same period of 2024. Channel inventory at the end of the second quarter of 2024 was within the normal range.
Opzelura:
Net product revenues for the second quarter 2024 of $122 million (+52% Y/Y):
- Net product revenues growth in the second quarter of 2024 were driven by patient demand, refills and expansion in payer coverage in both atopic dermatitis (AD) and vitiligo.
- Net product revenues of $11 million in the second quarter of 2024 in Europe. Incyte achieved full reimbursement in Spain and Italy at the end of the second quarter 2024 and in France in July 2024.
Additional Pipeline Updates
Myeloproliferative Neoplasms (MPNs) and Graft-Versus-Host Disease (GVHD) – key highlights
- Combination trials of ruxolitinib twice daily (BID) with zilurgisertib and BETi are ongoing and continue to enroll. A Phase 3 study for BETi is expected to advance into Phase 3 with an expected update later this year. Clinical proof-of-concept for zilurgisertib is anticipated in the second half of 2024.
- The Phase 1 studies evaluating mCALR and JAK2V617Fi are ongoing and enrolling patients. Initial data for both studies is anticipated in 2025.
|
MPN and GVHD Programs |
|
Indication and status |
|
Ruxolitinib XR (QD) (JAK1/JAK2) |
|
Myelofibrosis, polycythemia vera and GVHD |
|
Ruxolitinib + zilurgisertib (JAK1/JAK2 + ALK2i) |
|
Myelofibrosis: Phase 2 |
|
Ruxolitinib + INCB57643 (JAK1/JAK2 + BETi) |
|
Myelofibrosis: Phase 2 |
|
Axatilimab (anti-CSF-1R)1 |
|
Chronic GVHD: Pivotal Phase 2 (third-line plus therapy) (AGAVE-201); BLA under review in the U.S. |
|
Ruxolitinib + axatilimab1 (JAK1/JAK2 + anti-CSF-1R) |
|
Chronic GVHD: Phase 2 in preparation |
|
Steroids + axatilimab1 (Steroids + anti-CSF-1R) |
|
Chronic GVHD: Phase 3 in preparation |
|
INCA33989 (mCALR) |
|
Myelofibrosis, essential thrombocythemia: Phase 1 |
|
INCB160058 (JAK2V617Fi) |
|
Phase 1 |
|
1 |
Clinical development of axatilimab in GVHD conducted in collaboration with Syndax Pharmaceuticals. |
Other Hematology/Oncology – key highlights
|
Heme/Oncology Programs |
|
Indication and status |
|
Pemigatinib (Pemazyre®) (FGFR1/2/3) |
|
Myeloid/lymphoid neoplasms (MLN): approved in the U.S. and Japan Cholangiocarcinoma (CCA): Phase 3 (FIGHT-302) |
|
Tafasitamab (Monjuvi®/Minjuvi®) (CD19) |
|
Relapsed or refractory diffuse large B-cell lymphoma (DLBCL): Phase 3 (B-MIND) First-line DLBCL: Phase 3 (frontMIND) Relapsed or refractory follicular lymphoma (FL) and relapsed or refractory marginal zone lymphoma (MZL): Phase 3 (inMIND) |
|
Retifanlimab (Zynyz®)1 (PD-1) |
|
Merkel cell carcinoma (MCC): approved in the U.S. and Europe Squamous cell anal cancer (SCAC): Phase 3 (POD1UM-303) Non-small cell lung cancer (NSCLC): Phase 3 (POD1UM-304) MSI-high endometrial cancer: Phase 2 (POD1UM-101, POD1UM-204) |
|
INCB123667 (CDK2i) |
|
Solid tumors with Amplification/ Overexpression of CCNE1: Phase 1 |
|
INCB161734 (KRASG12D) |
|
Advanced metastatic solid tumors with a KRAS G12D mutation: Phase 1 |
|
INCA33890 (TGFßR2×PD-1)2 |
|
Advanced or metastatic solid tumors: Phase 1 |
|
1 |
Retifanlimab licensed from MacroGenics. |
|
2 |
Development in collaboration with Merus. |
Inflammation and Autoimmunity (IAI) – key highlights
Dermatology
Opzelura
- In March 2024, Incyte presented data at the 2024 AAD Annual Meeting from its randomized, placebo-controlled, Phase 2 study evaluating the safety and efficacy of ruxolitinib cream (Opzelura®) in adults with mild/moderate hidradenitis suppurativa (HS). At Week 16, patients receiving ruxolitinib cream 1.5% twice daily (BID) had significantly greater decreases from baseline versus placebo in total abscess and inflammatory nodule (AN) count, the primary endpoint of the study. The overall safety profile of ruxolitinib cream was consistent with previous data, and no new safety signals were observed. A Phase 3 study is expected to initiate in 2025.
- Ruxolitinib cream in other indications: Phase 2 studies in lichen planus and lichen sclerosus have completed enrollment. Two Phase 3 trials evaluating ruxolitinib cream in prurigo nodularis (PN) are ongoing.
Povorcitinib (INCB54707)
- The Phase 2, randomized, double-blind, placebo-controlled, dose ranging study evaluating the efficacy and safety of povorcitinib in participants with PN were presented at the 2024 AAD Annual Meeting with the study meeting its primary and secondary endpoints following 16 weeks of treatment across all dosing groups, reinforcing povorcitinib’s potential role in treating PN. A Phase 3 study in PN is expected to initiate in 2024.
- Two Phase 2 trials in asthma and chronic spontaneous urticaria are enrolling.
|
IAI and Dermatology Programs |
|
Indication and status |
|
Ruxolitinib cream (Opzelura®)1 (JAK1/JAK2) |
|
Atopic dermatitis: Phase 3 pediatric study (TRuE-AD3) Vitiligo: Approved in the U.S. and Europe Lichen planus: Phase 2 Lichen sclerosus: Phase 2 Hidradenitis suppurativa: Phase 2; Phase 3 expected to initiate in 2025 Prurigo nodularis: Phase 3 (TRuE-PN1, TRuE-PN2) |
|
Ruxolitinib cream + UVB (JAK1/JAK2 + phototherapy) |
|
Vitiligo: Phase 2 |
|
Povorcitinib (JAK1) |
|
Hidradenitis suppurativa: Phase 3 (STOP-HS1, STOP-HS2) Vitiligo: Phase 3 (STOP-V1, STOP-V2) Prurigo nodularis: Phase 3 expected to initiate in 2024 Asthma: Phase 2 Chronic spontaneous urticaria: Phase 2 |
|
INCB000262 (EP262) (MRGPRX2) |
|
Chronic spontaneous urticaria: Phase 2 Chronic inducible urticaria: Phase 1b Atopic dermatitis: Phase 2a |
|
INCB000547 (EP547) (MRGPRX4) |
|
Cholestatic pruritus: Phase 2a |
|
INCA034460 (anti-IL-15Rβ) |
|
Vitiligo: Phase 1 |
|
1 |
Novartis’ rights to ruxolitinib outside of the United States under our Collaboration and License Agreement with Novartis do not include topical administration. |
Other
|
Other Program |
|
Indication and Phase |
|
Zilurgisertib (ALK2) |
|
Fibrodysplasia ossificans progressiva: Pivotal Phase 2 |
Partnered
|
Partnered Programs |
|
Indication and Phase |
|
Ruxolitinib (Jakavi®)1 (JAK1/JAK2) |
|
Acute and chronic GVHD: Approved in Europe and Japan |
|
Baricitinib (Olumiant®)2 (JAK1/JAK2) |
|
AD: Approved in Europe and Japan Severe alopecia areata (AA): Approved in the U.S., Europe and Japan |
|
Capmatinib (Tabrecta®)3 (MET) |
|
NSCLC (with MET exon 14 skipping mutations): Approved in the U.S., Europe and Japan |
|
1 |
Ruxolitinib (Jakavi®) licensed to Novartis ex-U.S. for use in hematology and oncology excluding topical administration. |
|
2 |
Baricitinib (Olumiant®) licensed to Lilly: approved as Olumiant in multiple territories globally for certain patients with moderate-to-severe rheumatoid arthritis; approved as Olumiant in EU and Japan for certain patients with atopic dermatitis. |
|
3 |
Capmatinib (Tabrecta®) licensed to Novartis. |
2024 Second Quarter Financial Results
The financial measures presented in this press release for the three and six months ended June 30, 2024 and 2023 have been prepared by the Company in accordance with U.S. Generally Accepted Accounting Principles (“GAAP”), unless otherwise identified as a Non-GAAP financial measure. Management believes that Non-GAAP information is useful for investors, when considered in conjunction with Incyte’s GAAP disclosures. Management uses such information internally and externally for establishing budgets, operating goals and financial planning purposes. These metrics are also used to manage the Company’s business and monitor performance. The Company adjusts, where appropriate, for expenses in order to reflect the Company’s core operations. The Company believes these adjustments are useful to investors by providing an enhanced understanding of the financial performance of the Company’s core operations. The metrics have been adopted to align the Company with disclosures provided by industry peers.
Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used in conjunction with and to supplement Incyte’s operating results as reported under GAAP. Non-GAAP measures may be defined and calculated differently by other companies in our industry.
As changes in exchange rates are an important factor in understanding period-to-period comparisons, Management believes the presentation of certain revenue results on a constant currency basis in addition to reported results helps improve investors’ ability to understand its operating results and evaluate its performance in comparison to prior periods. Constant currency information compares results between periods as if exchange rates had remained constant period over period. The Company calculates constant currency by calculating current year results using prior year foreign currency exchange rates and generally refers to such amounts calculated on a constant currency basis as excluding the impact of foreign exchange or being on a constant currency basis. These results should be considered in addition to, not as a substitute for, results reported in accordance with GAAP. Results on a constant currency basis, as the Company presents them, may not be comparable to similarly titled measures used by other companies and are not measures of performance presented in accordance with GAAP.
Financial Highlights
Financial Highlights
(unaudited, in thousands, except per share amounts)
|
|
Three Months Ended |
|
Six Months Ended |
||||||||||
|
|
|
2024 |
|
|
|
2023 |
|
|
2024 |
|
|
|
2023 |
|
Total GAAP revenues |
$ |
1,043,759 |
|
|
$ |
954,610 |
|
$ |
1,924,648 |
|
|
$ |
1,763,283 |
|
|
|
|
|
|
|
|
|
||||||
|
Total GAAP operating (loss) income |
|
(478,130 |
) |
|
|
193,780 |
|
|
(386,232 |
) |
|
|
218,550 |
|
Total Non-GAAP operating (loss) income |
|
(378,801 |
) |
|
|
262,058 |
|
|
(217,618 |
) |
|
|
351,787 |
|
|
|
|
|
|
|
|
|
||||||
|
GAAP net (loss) income |
|
(444,601 |
) |
|
|
203,548 |
|
|
(275,053 |
) |
|
|
225,251 |
|
Non-GAAP net (loss) income |
|
(396,132 |
) |
|
|
223,029 |
|
|
(263,413 |
) |
|
|
307,606 |
|
|
|
|
|
|
|
|
|
||||||
|
GAAP basic EPS |
$ |
(2.04 |
) |
|
$ |
0.91 |
|
$ |
(1.24 |
) |
|
$ |
1.01 |
|
Non-GAAP basic EPS |
$ |
(1.82 |
) |
|
$ |
1.00 |
|
$ |
(1.19 |
) |
|
$ |
1.38 |
|
GAAP diluted EPS1 |
$ |
(2.04 |
) |
|
$ |
0.90 |
|
$ |
(1.24 |
) |
|
$ |
1.00 |
|
Non-GAAP diluted EPS1 |
$ |
(1.82 |
) |
|
$ |
0.99 |
|
$ |
(1.19 |
) |
|
$ |
1.36 |
|
1.All stock options and stock awards were excluded from the diluted share calculation for the three and six months ended June 30, 2024 because their effect would have been anti-dilutive, as we were in a net loss position. |
Revenue Details
Revenue Details
(unaudited, in thousands)
|
|
Three Months Ended |
|
% |
|
% |
|
Six Months Ended |
|
% |
|
% |
||||||||||
|
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
|||||||||
|
Net product revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
|
Jakafi |
$ |
705,973 |
|
$ |
682,384 |
|
3 |
% |
|
3% |
|
$ |
1,277,812 |
|
$ |
1,262,353 |
|
1 |
% |
|
1% |
|
Opzelura |
|
121,695 |
|
|
80,233 |
|
52 |
% |
|
52% |
|
|
207,419 |
|
|
136,785 |
|
52 |
% |
|
52% |
|
Iclusig |
|
26,862 |
|
|
29,087 |
|
(8 |
%) |
|
(7%) |
|
|
57,205 |
|
|
56,772 |
|
1 |
% |
|
—% |
|
Pemazyre |
|
20,269 |
|
|
21,572 |
|
(6 |
%) |
|
(6%) |
|
|
37,945 |
|
|
44,047 |
|
(14 |
%) |
|
(14%) |
|
Minjuvi/ Monjuvi |
|
31,116 |
|
|
13,159 |
|
136 |
% |
|
137% |
|
|
54,990 |
|
|
19,715 |
|
179 |
% |
|
179% |
|
Zynyz |
|
651 |
|
|
570 |
|
14 |
% |
|
NM |
|
|
1,118 |
|
|
570 |
|
96 |
% |
|
NM |
|
Total net product revenues |
|
906,566 |
|
|
827,005 |
|
10 |
% |
|
10% |
|
|
1,636,489 |
|
|
1,520,242 |
|
8 |
% |
|
8% |
|
Royalty revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
|
Jakavi |
|
99,317 |
|
|
90,448 |
|
10 |
% |
|
14% |
|
|
188,912 |
|
|
167,140 |
|
13 |
% |
|
16% |
|
Olumiant |
|
31,702 |
|
|
32,009 |
|
(1 |
%) |
|
4% |
|
|
62,291 |
|
|
66,164 |
|
(6 |
%) |
|
(3%) |
|
Tabrecta |
|
5,298 |
|
|
4,799 |
|
10 |
% |
|
NA |
|
|
10,532 |
|
|
8,976 |
|
17 |
% |
|
NA |
|
Pemazyre |
|
876 |
|
|
349 |
|
151 |
% |
|
NM |
|
|
1,424 |
|
|
761 |
|
87 |
% |
|
NM |
|
Total royalty revenues |
|
137,193 |
|
|
127,605 |
|
8 |
% |
|
|
|
|
263,159 |
|
|
243,041 |
|
8 |
% |
|
|
|
Total net product and royalty revenues |
|
1,043,759 |
|
|
954,610 |
|
9 |
% |
|
|
|
|
1,899,648 |
|
|
1,763,283 |
|
8 |
% |
|
|
|
Milestone and contract revenues |
|
— |
|
|
— |
|
— |
% |
|
—% |
|
|
25,000 |
|
|
— |
|
NM |
|
|
NM |
|
Total GAAP revenues |
$ |
1,043,759 |
|
$ |
954,610 |
|
9 |
% |
|
|
|
$ |
1,924,648 |
|
$ |
1,763,283 |
|
9 |
% |
|
|
|
NM = not meaningful |
|
NA = not available |
|
1.Percentage change in constant currency is calculated using 2023 foreign exchange rates to recalculate 2024 results. |
Product and Royalty Revenues Product revenues and product and royalty revenues for the quarter ended June 30, 2024 increased 10% and 9%, respectively, over the prior year comparative period, primarily driven by the following;
- Jakafi net product revenue increased 3% driven by a 9% increase in paid demand. Year over year net product revenue growth was lower than paid demand growth due to higher channel inventory levels at the end of the second quarter of 2023 versus the same period of 2024. Channel inventory at the end of the second quarter of 2024 was within the normal range.
- Opzelura net product revenue increased 52% due to continued growth in new patient starts and refills.
- Minjuvi/Monjuvi net product revenue increased 136% following the acquisition of the exclusive global rights to tafasitamab in February 2024.
- Jakavi royalty revenues increased 10%.
Operating Expenses
Operating Expense Summary
(unaudited, in thousands)
|
|
Three Months Ended |
|
% Change |
|
Six Months Ended |
|
% Change |
|||||||||||||
|
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
|
2023 |
|
|||||||
|
GAAP cost of product revenues |
$ |
76,634 |
|
$ |
68,326 |
|
|
12 |
% |
|
$ |
137,590 |
|
|
$ |
125,148 |
|
|
10 |
% |
|
Non-GAAP cost of product revenues1 |
|
70,899 |
|
|
62,150 |
|
|
14 |
% |
|
|
125,858 |
|
|
|
112,819 |
|
|
12 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||
|
GAAP research and development |
|
1,138,380 |
|
|
400,750 |
|
|
184 |
% |
|
|
1,567,640 |
|
|
|
807,391 |
|
|
94 |
% |
|
Non-GAAP research and development2 |
|
1,089,089 |
|
|
367,921 |
|
|
196 |
% |
|
|
1,477,526 |
|
|
|
743,541 |
|
|
99 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||
|
GAAP selling, general and administrative |
|
305,982 |
|
|
283,929 |
|
|
8 |
% |
|
|
606,238 |
|
|
|
599,535 |
|
|
1 |
% |
|
Non-GAAP selling, general and administrative3 |
|
262,572 |
|
|
263,030 |
|
|
— |
% |
|
|
539,907 |
|
|
|
557,047 |
|
|
(3 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||
|
GAAP (gain) loss on change in fair value of acquisition-related contingent consideration |
|
893 |
|
|
8,374 |
|
|
(89 |
%) |
|
|
437 |
|
|
|
14,570 |
|
|
(97 |
%) |
|
Non-GAAP (gain) loss on change in fair value of acquisition-related contingent consideration4 |
|
— |
|
|
— |
|
|
— |
% |
|
|
— |
|
|
|
— |
|
|
— |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||
|
GAAP (profit) and loss sharing under collaboration agreements |
|
— |
|
|
(549 |
) |
|
— |
% |
|
|
(1,025 |
) |
|
|
(1,911 |
) |
|
(46 |
%) |
|
1 Non-GAAP cost of product revenues excludes the amortization of licensed intellectual property for Iclusig relating to the acquisition of the European business of ARIAD Pharmaceuticals, Inc. and the cost of stock-based compensation. |
|
2 Non-GAAP research and development expenses exclude the cost of stock-based compensation, MorphoSys transition costs, and Escient acquisition related compensation expense related to cash settled unvested Escient equity awards and severance payments. |
|
3 Non-GAAP selling, general and administrative expenses exclude the cost of stock-based compensation, MorphoSys transition costs, and Escient acquisition related compensation expense related to cash settled unvested Escient equity awards and severance payments. |
|
4 Non-GAAP (gain) loss on change in fair value of acquisition-related contingent consideration is null. |
Cost of product revenues GAAP and Non-GAAP cost of product revenues for the quarter ended June 30, 2024 increased 12% and 14%, respectively, compared to the same period in 2023 primarily due to growth in net product revenues.
Research and development expenses GAAP and Non-GAAP research and development expense for the quarter ended June 30, 2024 increased 184% and 196%, respectively, compared to the same period in 2023 primarily due to $679.4 million of expense relating to the IPR&D assets acquired in the Escient acquisition, $12.5 million of Escient acquisition related compensation expense related to cash settled unvested Escient equity awards and severance payments, as well as continued investment in our late stage development assets. Excluding the upfront consideration paid related to the Escient transaction and other upfront and milestone payments, research and development expense for the quarter ended June 30, 2024 increased 13% compared to the same period in 2023 due to continued investment in our late stage development assets and timing of certain expenses.
Selling, general and administrative expenses GAAP selling, general and administrative expenses for the quarter ended June 30, 2024 increased 8% compared to the same period in 2023 primarily due to $21.5 million of Escient acquisition related compensation expense related to cash settled unvested Escient equity awards and severance payments and timing of consumer marketing activities and of certain other expenses. Excluding the upfront consideration paid related to the Escient transaction, selling, general and administrative expenses for the quarter ended June 30, 2024 were flat compared to the same period in 2023.
Other Financial Information
Change in fair value of acquisition-related contingent consideration The change in fair value of contingent consideration during the quarter ended June 30, 2024, compared to the same period in 2023, was due primarily to fluctuations in foreign currency exchange rates impacting future revenue projections of Iclusig.
Operating income GAAP and Non-GAAP operating income for the three months ended June 30, 2024 decreased 347% and 245%, respectively, compared to the same period in 2023, driven primarily by the aforementioned costs relating to the Escient acquisition.
Provision for income taxes The income tax expense for the three months ended June 30, 2024 was $54.8 million on a pre-tax loss of $389.8 million primarily due to the impact of non-tax deductible charges of $710.9 million associated with the acquisition of Escient.
Cash, cash equivalents and marketable securities position As of June 30, 2024 and December 31, 2023, cash, cash equivalents and marketable securities totaled $1.4 billion and $3.7 billion, respectively. The decrease in cash, cash equivalents and marketable securities during 2024 was driven primarily by the $2.0 billion share repurchase completed during June 2024, and the total cash consideration paid to Escient shareholders of $783 million.
Share Repurchase In June 2024, Incyte completed a $2.0 billion share repurchase reflecting our confidence in the future outlook of our business, the strength of our commercial portfolio and the clinical development pipeline. In total, approximately 33.3 million shares of common stock were repurchased at $60.00 per share and represented approximately 14.8% of our common shares outstanding at the time of the repurchase. As of June 30, 2024, there were 191.6 million common shares outstanding.
2024 Financial Guidance
Incyte is raising the low end of its full year 2024 Jakafi revenue guidance as well as updating its full year 2024 research and development guidance to reflect the ongoing impact of the acquisition of Escient Pharmaceuticals. The research and development guidance excludes $691 million of upfront consideration recorded relating to the acquisition of Escient Pharmaceuticals. Incyte is maintaining its full year 2024 other hematology/oncology revenue guidance, as well as its cost of product revenue and selling, general and administrative guidance. Incyte’s guidance is summarized below. Guidance does not include revenue from any potential new product launches or the impact of any potential future strategic transactions.
|
|
Current |
Previous |
|
Jakafi net product revenues |
$2,710 – $2,750 million |
$2,690 – $2,750 million |
|
Other Hematology/Oncology net product revenues(1) |
Unchanged |
$325 – $360 million |
|
GAAP Cost of product revenues |
Unchanged |
7 – 8% of net product revenues |
|
Non-GAAP Cost of product revenues(2) |
Unchanged |
6 – 7% of net product revenues |
|
GAAP Research and development expenses |
$1,755 – $1,800 million |
$1,720 – $1,760 million |
|
Non-GAAP Research and development expenses(3) |
$1,615 – $1,655 million |
$1,580 – $1,615 million |
|
GAAP Selling, general and administrative expenses |
Unchanged |
$1,210 – $1,240 million |
|
Non-GAAP Selling, general and administrative expenses(3) |
Unchanged |
$1,115 – $1,140 million |
|
1Pemazyre in the U.S., EU and Japan; Monjuvi and Zynyz in the U.S.; and Iclusig and Minjuvi in the EU. |
|
2Adjusted to exclude the amortization of licensed intellectual property for Iclusig relating to the acquisition of the European business of ARIAD Pharmaceuticals, Inc. and the estimated cost of stock-based compensation. |
|
3 Adjusted to exclude the estimated cost of stock-based compensation. |
About Incyte
A global biopharmaceutical company on a mission to Solve On., Incyte follows the science to find solutions for patients with unmet medical needs. Through the discovery, development and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Oncology and Inflammation & Autoimmunity. Headquartered in Wilmington, Delaware, Incyte has operations in North America, Europe and Asia.
For additional information on Incyte, please visit Incyte.com or follow us on social media: LinkedIn, X, Instagram, Facebook, YouTube.
